Active Ingredient
(in each tablet)
Phenylephrine HCl 10 mg
Suphedrine Pe
FDA Label NDC 63981-453
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Costco Wholesale Corporation for the product Suphedrine Pe (NDC 63981-453). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relives sinus congestion and pressure
Do Not Use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
When Using This Product
do not exceed the recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: do not use this product in children under 12 years of age
Other Information
- store at controlled room temperature 15°-30°C (59° to 86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium cardoxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Product Packaging
The product packaging shown below represents a sample of that currently in use. Additional packaging may aslo be available.
KIRKLAND
Signature™
COMPARE TO
SUDAFED PE™
active ingredient*
NDC 63981-453-69
ITEM # 111266
NON-DROWSY
SUPHEDRINE PE
Phenylephrine Hydrochloride 10 mg
Nasal & Sinus Decongestant Formula
Temporary Relief of:
√ Nasal Congestion
√ Sinus Pressure & Congestion
√ Hay Fever Symptoms
Actual Size
1 Pill Per Dose
144
TABLETS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0810F45369
Manufactured by:
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678
* Please review the disclaimer below.
